Immune Monitoring of Hepatitis C Under DAA Therapy

• Conditions: Hepatitis C

• Registration Number: NCT02904603
• Lead Sponsor: University of Regensburg

Brief Summary

Direct acting antivirals offer a new opportunity to monitor the immune response in Hepatitis C infection. In this study cytokine markers will be measured during therapy up to time point SVR 12 an correlated to clinical Parameters and regular laboratory findings.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Status Verified: 2016-09
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-13
• Study First Posted: 2016-09-19
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-21
• Primary Completion: 2016-11
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• written consent, age, HCV-RNA positive, DAA therapy

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of IP10 and related cytokines during treatment (ng/ml)	24 weeks (observation time under and after DAA therapy)	Screening for Biomarkers under DAA Therapy until timepoint SVR 12 (12 weeks treatment plus control 12 weeks after end of Treatment = 24 weeks)

Secondary Outcome Measures

Name	Time	Method
SVR 12	24 weeks (12 weeks treatment plus control 12 weeks after end of treatment)	Eradication of HCV RNA 12 weeks after end of Treatment (Treatment 12 weeks)
Change of inflammatory markers (ferritin ng/ml, CRP mg/l, PCT ng/ml) during treatment	24 weeks (observation time under DAA therapy)

Trial Locations

Locations (1)

University of Regensburg; 🇩🇪 Regensburg, Germany